Anemia Associated Chronic Kidney DiseasePhase 1NCT04470063
Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases.
A Phase 1 study testing DDO-3055 tablets in people with Anemia Associated Chronic Kidney Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites in China.
Trial summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anemia Associated Chronic Kidney Disease
- What is being tested?
- DDO-3055 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 12 sitesChina
- Study dates
- 17 Nov 2020to 31 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CKD anemia aged 18-70 years who were not on dialysis and were not expected to undergo dialysis during the study period, regardless of gender;
- Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI<28kg/m2;
- Signed informed consent.
Who cannot join
- Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
- Patients with acute coronary syndrome, stroke, thromboembolism (such as deep vein thrombosis or pulmonary embolism) or a history of seizures within 6 months before screening;
- Patients with uncontroll ed hypertension;
- New York Heart Association grade III or IV congestive heart failure at the time of screening;
- ALT,AST or total bilirubin exceeds 1.5 times the upper limit of normal value (ULN) during the screening period;
- Suffer from anemia other than CKD.
Show all 17Show fewer
- Patients with a history of chronic liver disease;
- Patients with active bleeding or known coagulopathy;
- Patients who have any previous organ transplant or plan to perform organ transplant;
- Intravenous iron supplementation within 1 month before screening;
- Used erythropoiesis stimulator (ESAs), hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), androgen, blood transfusion therapy within 3 months before screening;
- Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, and human immunodeficiency virus (HIV) antibody were positive;
- Patients with blood loss ≥400mL within 3 months before screening;
- Subjects who have taken other clinical trial drugs or are expected to have a legacy effect of the trial treatment;
- Participants who are unwilling to take contraception or male subjects who cannot guarantee not to donate sperm during the trial and within 30 days after the last dose; female subjects with fertility who did not use contraception for at least 14 days before dosing;or male and female subjects who did not agree to use physical contraception during the trial;
- Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening;
- According to the study physician's judgment, there may be any other anemia factors that may exist, any possibility to increase the risk of the study, affect the subject's compliance with the protocol, or affect the physical or psychological disease or condition of the subject to complete the study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
Cangzhou People's Hospital
Cangzhou, Henbei, 075000
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Sun Yat Sen memorial hospital Sun Yat Sen university
Guangzhou, Guangdong, 510000
The First Affiliated Hospital，Sun Yat-sen University
Guangzhou, Guangdong, 510080
Shandong Qianfo Mountain hospital
Jinan, Shandong, 250013
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330000
Zhongda Hospital Southeast Universtiy
Nanjing, Jiangsu, 210009
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266555
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518000
Yichang Central People's Hospital
Yichang, Hubei, 443000
About this study
Official title: A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multi-dose DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases-Randomized, Double-blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.
- Conditions
- Anemia Associated Chronic Kidney Disease
- Being tested
- DDO-3055 tablets, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDO-3055 tabletsDrug
Multi-dose for DDO-3055 tablets
PlaceboDrug
Multi-dose for Placebo
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Not described Receives: Drug: DDO-3055 tablets; Drug: Placebo |
| group B | Experimental | Not described Receives: Drug: DDO-3055 tablets; Drug: Placebo |
| group C | Experimental | Not described Receives: Drug: DDO-3055 tablets; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events to assess safety and tolerability.
Measured: up to 37 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start17 Nov 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia Associated Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470063
- Sponsor's protocol ID
- DDO-3055-104
- Status last verified
- Oct 2021
- First submitted
- 9 Jul 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multi-dose DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases-Randomized, Double-blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial.
- ClinicalTrials.gov ID
- NCT04470063
- Acronym / sponsor ID
- DDO-3055-104
- Conditions
- Anemia Associated Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis chronic kidney diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: DDO-3055 tablets, Drug: Placebo |
| group B | Experimental | Drug: DDO-3055 tablets, Drug: Placebo |
| group C | Experimental | Drug: DDO-3055 tablets, Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with CKD anemia aged 18-70 years who were not on dialysis and were not expected to undergo dialysis during the study period, regardless of gender;
- Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI<28kg/m2;
- Signed informed consent.
Key exclusion criteria (17 listed)
- Allergic constitution, suspected to be allergic to the study drug or any component in the study drug;
- Patients with acute coronary syndrome, stroke, thromboembolism (such as deep vein thrombosis or pulmonary embolism) or a history of seizures within 6 months before screening;
- Patients with uncontroll ed hypertension;
- New York Heart Association grade III or IV congestive heart failure at the time of screening;
- ALT,AST or total bilirubin exceeds 1.5 times the upper limit of normal value (ULN) during the screening period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDO-3055 tabletsMulti-dose for DDO-3055 tablets | Drug | group A, group B, group C |
| PlaceboMulti-dose for Placebo | Drug | group A, group B, group C |
Primary outcome
The incidence and severity of adverse events to assess safety and tolerability.
Time frame: up to 37 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
Related trials for Anemia Associated Chronic Kidney Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents
Anemia Associated With Chronic Kidney Disease
Not yet recruiting
Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis
Chronic Kidney Disease (Stages 3b-5), Anemia Associated With Chronic Kidney Disease
RecruitingObservational study
Real-World Study of Enarodustat for Anemia in Non-Dialysis CKD Patients
Anemia of Chronic Kidney Disease, CKD
Not yet recruitingPhase 3
Safety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis
Anemia Associated With Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DDO-3055 tablets in people with Anemia Associated Chronic Kidney Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events to assess safety and tolerability. (time frame: up to 37 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.